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The ventilator shortage crisis arising from the COVID-19 pandemic has led to a proliferation of cross-industry collaboration and open-sharing of technical know-how in a bid to boost production of these life-saving devices. But are there issues, like confidentiality or product liability to be aware of?
The demand for ventilators continues with unabated urgency especially in countries where the number of critically-ill COVID-19 patients escalate every day. The past month has seen governments issue a call to arms to non-medtech manufacturers to help combat the ventilator shortage crisis by providing production support, while medical device manufacturers are pulling out all stops to ramp up production of ventilators and critical care equipment.
Last week, GE Healthcare announced it is partnering with automotive manufacturer Ford to scale the production of ventilators. GE told FirstWord MedTech that Ford is "supporting to source parts through its local supply chain" and providing its production capabilities. GE Healthcare will share the specs with Ford for the manufacture of a simplified version of an existing GE ventilator, while the healthcare firm’s own facilities will focus on producing its current ventilators.
More recent announcements have also come from other global car manufacturers. Toyota said it is contributing to COVID-19 efforts by bringing into action its "idled" plants to manufacture ventilators, as well as personal protective equipment (PPE) like face masks and face shields, while General Motors is partnering with Ventec Life Systems to manufacture both the needed respiratory equipment and PPE.
To top this off, the biggest medical device company, Medtronic, today made the unprecedented move to publicly share the design specifications for its Puritan Bennett 560 (PB 560) ventilator and enable participants across industries to evaluate options for rapid ventilator manufacturing.
Meanwhile, British engineering company Dyson, most famous for its vacuum cleaners, is working with medtech development specialist, The Technology Partnership (TTP), to create a ventilator from scratch - dubbed the CoVent - and fulfil its order of around 10,000 of these devices from the UK government.
The wider view
These unprecedented times call for unprecedented action, and while cross-sector collaborations are not unheard of within the life sciences realm, the COVID-19 pandemic has pushed such partnering activities to new levels.
But would there be issues arising from these partnerships and from such open sharing of know-how?
Tim Worden, a partner at global law firm Goodwin Procter who specialises in IP and commercial agreements within life sciences, acknowledged that the disclosure of confidential know-how has always been a challenging area for companies wanting to protect their "secret sauce."
"There’s always an inherent risk, whatever the circumstances, that if you disclose confidential information to a third party, you can’t guarantee that it will be kept confidential and only used for a permitted purpose. This know-how is usually protected purely by confidentiality and limited use obligations. But there’s no reason to believe that the counterparty wouldn't comply with the confidentiality terms and I think now more than ever, given the pandemic, one would expect it to be respected."
One thing that has struck Worden about partnerships like that between Dyson and TTP is how these would be collaborations "people may not have thought about in normal times, or they may not have entertained because they would have been busy focusing on their core business."
"But in these times, it seems companies have thought differently as to how they might collaborate across sectors and across industries." In addition to the increased openness between industry players, Worden remarked on the speed at which regulators around the world are responding to the COVID crisis - their recognition of the need to be flexible in relation to the application of relevant regulations and providing a special pathway for the rapid manufacture of ventilations systems, while at the same time still weighing the risks and benefits to ensure the products are going into market are safe.
Indeed, while these are unusual times for medtech companies to operate in, with regulations being loosened from sheer necessity, the rules around product liability appear not to have changed.
When asked who would get the blame if a ventilator that came from one of these newly forged cross-industry collaborations go wrong and potentially cause injury, Worden pointed out that under current European medical device legislation, it is the company that gets the CE mark for the product and places it on the market that would be liable.
Hypothetically, if Company A and Company B co-developed a device, but it is Company A that gets the product through the regulators and places it on the market, Company A would be the one to shoulder the blame under the medical devices legislation if the device was to go wrong.
Worden said "the two collaborating partners could determine within their contract the extent to which they may share liability or, if the issue turned out to be related to the supplier of a particular device component, seek to impose liability on the relevant company in the supply chain. But under more general product liability legislation, any player in the chain of getting a product to market is in principle liable under European legislation."
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